Test your Contraception IQ – 4

th Be a Contraceptive Mythbuster!

Edition

Dr. Dustin Costescu, MD FRCSC Contraception Advice Research and Education Fellow Queen’s University, Kingston ON

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Faculty/Presenter Disclosure

• Faculty: Dr. Dustin Costescu, MD FRCSC • Program: 51

st Annual Scientific Assembly

• Relationships with commercial interests: – Speakers Bureau/Honoraria: Pfizer, Bayer – Consulting Fees: Bayer, Pfizer

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Disclosure of Commercial Support

• This program has received financial support from the Society of

Obstetricians and Gynaecologists of Canada and the Foundation for Sexual and Reproductive Health in the form of an unrestricted educational grant.

• This program has received in-kind support from the Society of

Obstetricians of Canada in the form of logistical support.

• Potential for conflict(s) of interest: • Dr. Dustin Costescu has not received payment from any organization

supporting this program of from organizations whose products are being discussed in this program.

• The Society of Obstetricians and Gynaecologists of Canada holds the

copyright to this presentation.

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Mitigating Potential Bias

• Potential Biases are mitigated as follows: – Grants were provided by medical organizations in an unrestricted fashion.

– Content was reviewed by six national experts in contraception to minimize bias.

– No pharmaceutical company has had prior access or editorial input into content – Questions and cases were derived from consultations through our contraception clinic, and were not provided from external sources

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Learning Objectives

At the end of this session, the participant will be able to: – Separate fact from myth with respect to common beliefs about birth control – Identify opportunities to change contraceptive practices, reduce failure, and improve satisfaction – Reassure patients about the relative safety of contraception and provide information with confidence

Overview

Patients are bombarded by complex messages about birth control and reproduction: – Media Reports – Sociocultural Expectations – Advice from Healthcare Providers The challenge of contraceptive management lies in anticipating and addressing patient concerns, while ensuring that advice is based upon high-quality evidence.

Let’s Begin!

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Question 1.

The only contraceptive jelly available in Canada for use with caps and diaphragms has equivalent efficacy to older, Nonoxynol-9 containing products.

1. True 2. False

• • • The currently available jelly is not a spermicide.

There are no published studies on efficacy There are no head to head trials comparing Lactic Acid-Based products to NN-9.

•

The one-year failure rate for a diaphragm without spermicide is 29%

Hatcher et al. “Contraceptive Technology” 20 th ed. 2011 p.397

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Question 2.

What is the primary mechanism of contraception of the Levonorgestrel Releasing Intrauterine System (LNG-IUS)?

1. Change in cervical mucus 2. Endometrial Atrophy 3. Ovulatory Suppression 4. Apoptosis of gametes

Cervical Mucus

• Like all progestin-only methods, the central mechanism of action of the LNG-IUS is mediated by cervical mucus.

• The LNG-IUS primarily acts prior to fertilization • The increased viscosity of the mucus may explain the decreased risk of PID seen in LNG-IUS users compared to copper IUD users.

J. Toivonen, T. Luukkainen, H. Allonen. “Protective effect of intrauterine release of levonorgestrel on pelvic infection: three years' comparative experience of levonorgestrel- and copper releasing intrauterine devices” Obstet Gynecol, 77 (1991), pp. 261–264

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Question 3.

Men who find condoms to be too loose should look for products that offer what feature?

1. “Snug” 2. “Thin” 3. “Sensitive” 4. “Latex Free”

Snug = Smaller Condoms

• • • Self-reported penile measurements are associated with condom “Fit and Feel” problems.

For men who complain of condoms feeling too loose, where there is difficulty in sustaining erection, or where self-reported penile size is small, suggest condoms that offer a “snug” fit.

Condom size varies by country, and men can order many different sizes via the internet.

Reece M, Herbenick D, Dodge B. “Penile dimensions and men’s perceptions of condom fit and feel” Sex Transm Infect 2009;85:127-31

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Question 4.

VTE risk is decreased in users of the vaginal contraceptive ring because of the elimination of first-pass effect.

1. True 2. False

• Although the first-pass is avoided, there is sufficient drug in second and third passes to cause changes in the coagulation cascade.

• VTE risks are roughly similar between users of transdermal, vaginal, or oral combined hormonal contraception.

Cedars MI, Judd HL Nonoral routes of estrogen administration. Obstet Gynecol Clin North Am 1987;14:269 298.

Liddegaard Ø, Hougaard Nielsen L, Wessel Skovlund C, Løkkegaard E. “Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10.” BMJ 2012;344:e2990

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Question 5.

Because of its effects on cytochrome P450, grapefruit juice can be associated with breakthrough bleeding with the combined oral contraceptive pill.

1. True 2. False

• Ethinyl Estradiol is metabolized through the CYP450 pathway, as is grapefruit juice.

• Grapefruit juice may potentiate Ethinyl Estradiol (increasing bioavailability). Infrequent grapefruit consumers may experience breakthrough bleeding from fluctuations in EE levels.

• Contraceptive Efficacy is preserved, because EE levels increase, not decrease. Weber A, Jager R, Borner A et al. “Can grapefruit juice influence ethinylestradiol bioavailability?” Contraception 1996;53:41-7.

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Question 6.

How soon following a term delivery can a woman who is not breastfeeding ovulate?

1. Two weeks 2. Four weeks 3. Six weeks 4. Twelve weeks

Ovulation can occur by 26 days postpartum

• In just over 3 weeks, a woman’s fertility may be restored.

• Many couples do not wait for permission to resume intercourse.

• Contraceptive planning should take place prior to discharge, or at an interval visit before the traditional 6-week follow-up.

Speroff L, Mishell DR. “The postpartum visit: it’s time for a change in order to optimally initiate contraception” Contraception 2008;78”:90-8.

Discussion Case 1

• There are various strategies for determining if and when, during a woman’s menstrual cycle, that intrauterine contraceptives can be placed. – E.G. Some providers only insert IUDs during menses.

• • • What strategy do you currently employ?

Does this strategy create access barriers to patients?

How would you counsel patients who are at risk of pregnancy and want an IUD inserted?

When to insert IUDs

• According to the monograph, it is recommended that the Nova-T is inserted at the end of menses; the LNG-IUS should be inserted within seven days of the onset of menses.

• This potentially creates barriers due to scheduling, access for multiple visits, and the chance of interval pregnancy if the woman is inadequately protected.

• According to the WHO-SPR, a copper IUD can be inserted in all women up until day 12 of the cycle, and day 7 for LNG-IUS. It can also be inserted in women if

she is reasonably certain not to be pregnant.

Ruling out Pregnancy*

You can be reasonably certain that the woman is not pregnant if no symptoms of pregnancy and meets any criterion: • • • • • • has not had intercourse since last normal menses has been correctly and consistently using a reliable method of contraception is within the first 7 days after normal menses is within 4 weeks postpartum for non-lactating women is within the first 7 days postabortion or miscarriage is fully or nearly fully breastfeeding, amenorrheic, and less than 6 months postpartum *

Some clinics and hospitals require a negative urine pregnancy test.

WHO Selected Practice Recommendations (SPR)

• • Provides practical information about contraceptive management – initiation, follow-up, and discontinuation.

Designed for use in high and low-resource settings.

• Download it here! – WHO Website

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Question 7.

In a woman switching from condoms (which she is using consistently) to a Levonorgestrel-IUS, for how long should she bridge/ backup with condoms?

1. None is needed 2. 2 Days 3. 5 Days 4. 7 Days

7 Days

• • • 7 days are recommended, according to the WHO Selected Practice Recommendations for Contraceptive Use.

The LNG-IUS may not be immediately effective, as time is needed to increase levels of LNG.

LNG-IUS has not been demonstrated to have post coital effects, so caution is needed when inserting a device mid-cycle.

WHO. Selected Practice Recommendations for Contraceptive Use, 2 nd Ed 2004.

Natavio et al. Temporal Changes in cervical mucus after insertion of the levonorgestrel-releasing intrauterine system. Contraception 2013;87:426-31.

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Question 8.

Your patient is going to be away the week she is due for her DMPA injection. The SOGC recommends that, relative to the last injection, the next is given: 1. Within 13 weeks 2. Within 14 weeks 3. Within 16 weeks 4. Within 17 weeks

14 weeks

• •

The SOGC recommends that repeat doses are

given within 14 weeks post injection, as ovulation is unlikely to occur in that time.

– In low-resource countries, the WHO has revised its recommendation to within 16 weeks, as pregnancies are still rare.

Women should receive their injections on time when possible.

– However, if a woman is late, she can be reassured by the “grace period” – Otherwise, she may not return at all, assuming that a failure is likely.

Guilbert E, Black A, Dunn S et al. “SOGC Committee Opinion. Missed Hormonal Contraceptives: New Recommendations” JOGC 2008; 30:1050-62.

WHO. Selected Practice Recommendations for Contraceptive Use, 2 nd Ed 2004.

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Question 9.

Oral contraceptives containing Cyproterone Acetate (CPA/EE) increase the risk of VTE compared to similar users of second-generation (LNG/EE) combined hormonal contraceptives.

1. True 2. False

• • • • • There have been no recently reported deaths related to CPA/EE. Health Canada and the European Medicines Agency have concluded that the benefits of CPA/EE outweigh risks.

Most evidence suggests no increased risk of VTE VTE risk increases with EE dose, and CPA/EE contains 35 mcg A significant confounding variable in CPA/EE users is by indication. As an anti-androgen, CPA is used for the management of hirsutism and acne, which is increased in conditions such as Polycystic Ovarian Syndrome (PCOS). Women with PCOS are at increased risk of VTE.

SOGC “Position Statement: Diane-35 and Risk of Venous Thromboembolism (VTE).

http://sogc.org/wp-content/uploads/2013/04/medDiane35VTE130219.pdf

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Question 10.

In perimenopausal women without contraindications to estrogen, at what age should contraception be stopped?

1. 52 2. 53 3. 54 4. 55

Stop Contraception at 55

• Based on expert opinion – – Probability of pregnancy Cardiovascular Risk/Benefit – Non-Contraceptive Benefits • Hormone Therapy is inadequate to act as a contraceptive!

European Society of Human Reproduction and Embryology. Female contraception over 40. Hum Reprod Update 2009;15: 599 –612.

Question 11.

Which laboratory test is most reliable in the management of a woman taking the OCP who wishes to stop prior to 55?

32 1. Day 3 FSH testing x 2 cycles 2. FSH testing on last day of HFI x 2 cycles 3. Switch to Progestin-only method and check FSH after 6 weeks x 2 cycles 4. Use barrier methods and if amenorrheic x 6 months, stop.

• • • •

FSH testing and Discontinuation of Contraception

As Estrogen inhibits FSH, day 3 testing is

unreliable.

Day 7 testing (at end of HFI) can be done, but if FSH is low, this may be due to hormonal suppression.

Progestins do not have a significant effect on FSH, therefore switching to a POP and performing FSH testing is the most reliable indicator and is the most correct answer.

Women should be amenorrheic for a year before discontinuing contraception – six months is inadequate.

FSRH, 2010 “Contraception for Women aged over 40 years” http://www.fsrh.org/pdfs/ContraceptionOver40July10.pdf

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Question 12.

Which woman is at risk of contraceptive failure from lactational amenorrhea?

1.

2.

3.

4.

7 months postpartum, amenorrheic, exclusively breastfeeding.

5 months postpartum, amenorrheic, pumping every 4 hours in day, sleeping through the night.

4 months postpartum, scant bleeding three weeks ago, not as heavy as a period, breastfeeding exclusively.

All of the above

All of the Above

Only women who are –

Exclusively breastfeeding

• No more than 4 hours between feeds in day and 6 at night – – Less than 6 months postpartum, and

Amenorrheic

can rely on LAM.

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Question 13.

Levonorgestrel-Only Emergency Contraception (LNG-EC) is effective throughout the menstrual cycle.

1. True 2. False

• • LNG-EC blocks the LH surge and ovulation.

It is only effective in the follicular phase. • EC should be used liberally as many women have difficulty knowing when they are ovulating when they are not deliberately tracking cycles in an attempt to conceive Noe G, Croxatto HB, Salvatierra AM, et al. “Contraceptive Efficacy of emergency contraception with levonorgetrel given before and after ovulation” Contraception 2011;84:486-92.

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Question 14.

Which is the ONLY anti-epileptic drug that must be dose-adjusted if a woman starts combined hormonal contraception?

1. Carbamazepine 2. Valproic Acid 3. Phenobarbitol 4. Lamotrigine

Lamotrigine is special!

• • • • Due to glucuronidation of the drug, which is potentiated by EE metabolism. Clearance increased by 50% and can lead to loss of seizure control.

Slight decrease in progestin concentration, likely no effect on efficacy If CHC is stopped the dose must be decreased.

Sidhu J, Job S, Singh S, Philipson R. The pharmacokinetic and pharmacodynamic consequences of the co administration of lamotrigine and a combined oral contraceptive in healthy female subjects. Br J Clin Pharmacol. 2006;61:191-9.

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Discussion Case 2.

By which means do you perform STI screening in women prior to insertion of an Intrauterine Contraceptive?

1.

2.

3.

4.

5.

Screen all patients the day of insertion. Screen selected patients, based on risk factors, the day of insertion.

Screen at the first visit, and insert once negative result obtained.

Routine antibiotic prophylaxis Do not offer IUD for patients at risk of STI

STI screening and IUDs

• • • • Recent data suggests the risk of PID with insertion of an IUD is very low – 0.5%. Same day screening by risk factor (<25, multiple partners), is as effective at reducing infection as two day screening without the added barrier of multiple visits.

Avoid insertion is overt signs of infection.

SBE prophylaxis not indicated.

Sufrin CB, Postlethwaite D, Armstrong MA, Merchant M, Wendt JM, Steinauer JE. Neisseria gonorrhea and Chlamydia trachomatis screening at intrauterine device insertion and pelvic inflammatory disease. Obstet Gynecol. 2012;120:1314-21

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Question 15.

Measurement of the uterine cavity can assist in determining whether or not a “small” or “short” IUD should be used.

1. True 2. False

• • • There is no clear association between uterine cavity size and expulsion for “normal” size CuIUD or LNG IUS.

The uterine cavity of a nulliparous woman is only about 0.28cm shorter than a parous uterus, which is of uncertain significance The decision to use smaller-sized IUDs is based on clinical judgement, not evidence-based criteria.

Canteiro R, Bahamondes MV, dos Santos Fernandes A, Espejo-Arce X, Marchi NM, Bahamondes L. Length of the endometrial cavity as measured by uterine sounding and ultrasonography in women of different parities. Contraception. 2010 Jun;81(6):515-9.

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Question 16.

Taking a “Pill Vacation” (periodically taking a month off) decreases exposure to estrogen and VTE risk.

1. True 2. False

• • VTE risk is highest in the first 3 months following initiation of estrogen.

– Due to fluctuations in coagulation factors which return to normal thereafter.

Following discontinuation of estrogen for ≥4 weeks, there is a new alteration in coagulation factors with resumption, and

VTE risk increases as well.

Dinger J, Mohner S, Minh TD. Early Use Effects on the Risk of Venous Thromboembolism After the Initiation of Oral Contraceptive Use. Presented at 11th ESC Congress May 19-22 2010, Netherlands.

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Question 17.

Women with a laparoscopic adjustable gastric band (“Lap Band”) should avoid oral contraceptives.

1. True 2. Avoid for one year, then no contraindication 3. Avoid for two years, then no contraindication 4. False

• • Women with restrictive procedures (sleeve gastrectomy, laparoscopic adjustable gastric band, vertical banded gastroplasty) have no restrictions –

USMEC – 1

However any procedure with a malabsorptive component (Roux en Y, Duodenal Switch, Biliopancreatic Diversion) are not recommended, largely based on theoretical risk. –

USMEC - 3

CDC. “U.S. Medical Eligibility Criteria for Contraceptive Use, 2010” MMWR 2010:59(RR04):1-6.

Medical Eligibility Criteria for Contraceptive Use

• Helpful when deciding if a medical condition precludes the use of certain contraceptive methods.

1 = No Contraindication 2 = Benefit generally > Risk 3 = Risk generally > Benefit 4 = Contraindicated QR CODE FOR US-MEC App Store – Apple Website – Other Device

Question 18.

Bone mineral density changes of the spine and hip are NOT observed with the Etonorgestrel Implant* 1. True 2. False 49 * Not Available in Canada at present time.

• • • There is less gonadotropin and estrogen suppression in implant users than DMPA. Studies comparing implant users to non-users fail to show differences in BMD for hip and spine. One study showed a decrease in ulnar but not radial BMD in etonorgestrel, but this is of limited clinical significance.

Sarfatib J, de Vernejoula MC. Impact of combined and progestogen-only contraceptives on bone mineral density. Joint Bone Spine. 2009;76:134-8.

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Question 19.

Family History of VTE is a simple and sensitive means to assess a patient’s risk of inherited thrombophilia.

1. True 2. False

• • Sensitivity of Family History is 16-63% Positive Predictive Value is 6-50% • Family history of VTE is no better than flipping a coin as a screening tool for thrombophilia, and is not useful in determining suitability for contraception.

Grimes DA, Stuart GS, Levi EE. Screening women for oral contraception: can family history identify inherited thrombophilias? Obstet Gynecol 2012;120:889-95.

Does my patient need thrombophilia testing?

• Patients who have a family history of VTE (genotype) AND relatives with a known inherited thrombophilia (phenotype) may benefit from testing.

– Personal Hx of VTE or Thrombophilia are contraindications to Estrogen-containing contraception (USMEC- 4) – Otherwise, benefits outweigh risk (USMEC – 2) 53 • Screening is not cost effective – Must test 666 female relatives of a proband with Factor V Leiden to prevent one case of VTE related to OCP use.

Middeldorp S. “Evidence-based approach to thrombophilia testing” J Thromb Thrombolysis 2011;31:275-81.

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Question 20.

Sufficient evidence now exists to conclude that contraceptives containing Drospirenone (DRSP/EE) are associated with increased risk of VTE when compared to those containing Levonorgestrel (LNG/EE).

1. True 2. False

• • • • Several retrospective studies using data from administrative databases suggest a small increased risk of VTE among users of DRSP/EE compared to LNG/EE containing pills. Two large, adequately powered prospective studies have failed to show differences in VTE.

If a true difference exists, it is no higher than “third generation” desorgestrel- or gestodene-containing pills. If a true difference exists, the attributable risk is 0.024% – One additional VTE per 4167 women using 4 th generation instead of 2 nd Bitzer J et al. “Statement on combined hormonal contraceptives containing third- or fourth-generation progestogens or cyproterone acetate, and the associated risk of thromboembolism” J Fam Plann Reprod Health Care doi:10.1136/jfprhc-2013-100624

Discussion Case 3

• There are many factors that influence the decision to seek tubal sterilization, notably differences in race, socioeconomic status, and family experience (women whose mother’s had a tubal ligation are more likely to request one).

• Because of the advent of highly acceptable LARC methods (many of which can be used beyond their monograph-recommended durations), the informed consent process has changed.

• What strategies do you find effective in helping women choose between LARC and Tubal Sterilization (or vasectomy)? What are the key aspects of informed consent that you cover if a woman still desires tubal sterilization?

Evaluation (For future program development)

57 The Society of Obstetricians and Gynaecologists of Canada (SOGC) | Annual Clinical Meeting | Calgary, Alberta | June 11-14, 2013

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The questions in this presentation were:

1) Too hard to enjoy the talk 2) Hard, but encouraged learning on the subject 3) Easy, but encouraged learning and discussion 4) Too easy to enjoy the talk

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The questions in this presentation were free from commercial bias:

1) Strongly Agree 2) Agree 3) Neutral 4) Disagree 5) Strongly Disagree

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There is interest in making an easier talk for those seeking a more general review of contraceptive myths. Such a program would be:

1) Not useful 2) Potentially useful to providers I work with or receive referrals from.

3) Potentially useful for me and my peers 4) Useful for a large audience such as this

Thank you!

• This program is made possible by: – The Foundation for the Promotion of Sexual and Reproductive Health – The Society of Obstetricians and Gynaecologists of Canada • Contraception Awareness Project